Quality Engineering

Johnson & Johnson Innovative Medicine•San Lorenzo, PR

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Requirements

A minimum of a Bachelors or equivalent University degree is required with a preferred focus in Engineering or Applied Science.
A minimum of 2 years of work experience with a minimum of one (1) years of related experience in a regulated industry is required; Medical Device experience is preferred.
Intermediate or higher computer skills and use of software application(s).
Fully bilingual (Spanish & English)
Knowledge of QSR and ISO Standards.

Nice To Haves

EIT, PE License preferred.

Responsibilities

Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).
Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business.
Lead and/or support Plant Initiatives and/or special projects.
Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.
Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.
Performs other tasks as assigned by the Quality Operations Lead, Quality Operations Leader or and/or Site Quality Lead.
Develop, write and approve as required policies, procedures, test methods, specifications.
Support the Plant Sterilization processes.
Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments.
Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR’s and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas.
Approve and support the control and disposition of non-conformance material as per applicable procedures.
Perform product impact assessments and the determination of non-conformances scope (i.e. bounding).
Attend and support Operation meetings.
Support manufacturing in the day-to-day troubleshooting situations and actively participates on Integrated Production Team’s (IPT).
Acts as a designated Quality Operations Lead or Quality Operations Leader when needed.
Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.